Predicting Disease Progression and/or Recurrence in Cancer

Brief Title

Predicting Disease Progression and/or Recurrence in Cancer

Official Title

Tumor Markers, Liquid Biopsies, and Patient Reported Outcomes in Metastatic Colorectal, Pancreas, Biliary, and Esophagogastric Cancers

Brief Summary

      This is a prospective study addressing the challenge of predicting disease progression and/or
      recurrence in patients diagnosed with metastatic colorectal, pancreatobiliary, or
      esophagogastric cancer that are receiving anti-cancer therapy.
    

Detailed Description

      This research study is evaluating how patient-reported outcomes (e.g. symptoms, quality of
      life) and biomarkers compare to standard of care clinical assessments such as imaging and
      tumor markers in predicting the clinical outcomes (e.g. disease progression and survival) in
      patient populations with colorectal, pancreatobiliary, or esophagogastric cancer that are
      receiving anti-cancer therapy Massachusetts General Hospital Cancer Center

        -  Patient reported outcomes will be collected through a series of self-administered
           questionnaires and blood draws will be used to obtain bio and tumor marker information.

        -  Information will also be collected from the participants electronic medical record.

        -  Tissue may be obtained for next-generation sequencing.

        -  The study will conclude after participants are no longer receiving anti-cancer
           therapies.

        -  It is expected that about 600 people will take part in this research study
    

Study Type

Observational

Primary Outcome

Treatment Response at 1st Scan

Secondary Outcome

 Treatment Response at 1st Scan - Continuous Outcome

Condition

Patient Reported Outcome Measures

Intervention

Observational Cohort

Study Arms / Comparison Groups

 Main Cohort

Description:  Patient-reported outcomes (e.g. symptoms, quality of life) and biomarkers compare to standard of care clinical assessments such as imaging and tumor markers in predicting the clinical outcomes (e.g. disease progression and survival)
Prior to starting anti-cancer therapy and at subsequent designated visits (every one month)
Collections include:
Blood sample
Questionnaires quality of life, mood, and symptoms
Tissue may be obtained for next-generation sequencing.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Behavioral

Estimated Enrollment

600

Start Date

April 30, 2019

Completion Date

April 2024

Primary Completion Date

April 2023

Eligibility Criteria

        -  Inclusion Criteria:

               -  Patients must have histologically confirmed colorectal, pancreatobiliary, or
                  esophagogastric cancer.

               -  Diagnosed with metastatic disease

               -  Age > 18 years.

               -  Patients must be starting new line of anti-cancer therapy.

               -  Patient must be English-speaking.

          -  Exclusion Criteria

          -  Unwilling or unable to participate in the study

          -  Non-metastatic disease

          -  Not starting new anti-cancer treatment

          -  Cognitive issues interfering with ability to participate.

          -  Active, unstable, untreated serious mental illness interfering with ability to
             participate.

          -  Patient does not speak English.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Aparna R Parikh, MD, MS, (617) 724-4000, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT04776837

Organization ID

18-380

Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Study Sponsor

Aparna R Parikh, MD, MS, Principal Investigator, Massachusetts General Hospital

Verification Date

February 2021